Cleared Traditional

K030887 - LEKTROGEL, MODEL LK3001

K030887 is an FDA 510(k) clearance for LEKTROGEL, manufactured by Inmed Ltda.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K030887 · Inmed Ltda. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
84d
Days
Class 2
Risk

K030887 is an FDA 510(k) clearance for the LEKTROGEL, MODEL LK3001. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Inmed Ltda. (Alpharetta, US). The FDA issued a Cleared decision on June 13, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K030887

510(k) Number K030887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2003
Decision Date June 13, 2003
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 149d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GYB Media, Electroconductive

All 61
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K030887.
ELECTRO-GEL
K111717 · Electro-Cap Intl., Inc. · Jan 2012
THERA-CREAM, MODEL TCT004
K032239 · Prizm Medical, Inc. · Jul 2004
CONDUCTIVE EEG ELECTROLYTE
K033052 · Compumedics USA, Ltd. · Dec 2003
HOME CARE JELLY
K022494 · Roc Chinese-European Industrial Research Society · Dec 2002
CONDUCTIVE GEL
K022006 · The Dezac Group · Sep 2002
MAVIDON MEDICAL ELECTRODE JELLY
K003924 · Mavidon Medical Products · Aug 2001
K030887 · LEKTROGEL, MODEL LK3001
Download PDF FDA Summary Inmed Ltda.